Ganciclovir sodium adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Ganciclovir sodium
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Cytomegalovirus nucleoside analog DNA polymerase inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 568 adverse event reports that name Ganciclovir sodium. In these reports the drug is a suspect or interacting product.

In the same period, 139 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 86 reports in the 12 months to June 2026 and 73 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 86 (under 0.1%) name Ganciclovir sodium. Reports from other health professionals were 62% of the reports that name Ganciclovir sodium and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Ganciclovir sodium is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 15 reports that name Ganciclovir sodium.
In January to March 2026, FDA received 37.
In April to June 2025, FDA received 16.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 52 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 523 of the 568 reports (92.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 52 terms.

Reaction terms in the reports that name Ganciclovir sodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 568 reports
Off label useused for a purpose or in a way not on the label	149	26.2%
Drug ineffectivethe medicine did not work as expected	97	17.1%
Drug ineffective for unapproved indication	59	10.4%
Neutropenialow neutrophils, a type of white blood cell	56	9.9%
Cytomegalovirus infection	54	9.5%
Drug resistance	52	9.2%
Condition aggravatedthe condition being treated got worse	31	5.5%
Product use in unapproved indicationused for a purpose not on the label	31	5.5%
Pancytopenialow counts of all blood cells	19	3.3%
Treatment failurethe treatment did not work	18	3.2%
Myelosuppression	17	3%
Aspergillosis	16	2.8%
Cytomegalovirus infection reactivation	15	2.6%
Leukopenialow white blood cells	15	2.6%
Cytomegalovirus chorioretinitis	13	2.3%
Multiple organ dysfunction syndromeseveral organs failing	13	2.3%
Renal impairmentreduced kidney function	13	2.3%
Stenotrophomonas infection	13	2.3%
Thrombocytopenialow platelets	12	2.1%
Brain oedema	11	1.9%
End stage renal diseasekidney failure needing dialysis or transplant	11	1.9%
Enterococcal infection	11	1.9%
Respiratory failurethe lungs could not supply enough oxygen	11	1.9%
Blood pressure fluctuation	10	1.8%
Brain abscess	10	1.8%
Cytomegalovirus colitis	10	1.8%
Fusarium infection	10	1.8%
Intracranial infection	10	1.8%
Nephropathy toxic	10	1.8%
Renal failurekidney failure	10	1.8%
Acute kidney injurysudden loss of kidney function	9	1.6%
Disease progressionthe disease advanced	9	1.6%
Bone marrow failure	8	1.4%
Deaththe patient died; cause not stated by this term	8	1.4%
Pathogen resistance	8	1.4%
Retinal toxicity	8	1.4%
Septic shockshock arising from infection	8	1.4%
Diarrhoealoose or frequent stools	7	1.2%
Imprisonment	7	1.2%
Multi-organ failure	7	1.2%
Product use issuea problem in how the product was used	7	1.2%
Acute graft versus host disease in skin	6	1.1%
Retinal disorder	6	1.1%
Visual impairmentreduced vision	6	1.1%
Acidosis	5	0.9%
Agranulocytosis	5	0.9%
Encephalitis cytomegalovirus	5	0.9%
Intentional product use issuedeliberate use not as intended	5	0.9%
Myocardial calcification	5	0.9%
Pneumonia cytomegaloviral	5	0.9%

Download all 52 terms of Ganciclovir sodium (CSV)

The counts add to more than 568 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Ganciclovir with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ganciclovir	Generic name	4,729
Ganciclovir sodium (this page)	Generic name	568

Sum of the separately reported names: 5,297. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Ganciclovir sodium, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	13	13	6	4	9	0	0	2	0
2005	2	2	1	0	2	0	0	1	0
2006	8	8	1	1	2	2	0	4	0
2007	23	23	12	2	13	1	0	3	0
2008	11	11	6	1	6	1	0	5	0
2009	40	40	29	0	13	0	0	25	0
2010	31	31	15	1	8	1	0	26	0
2011	35	35	9	5	17	3	0	15	0
2012	20	20	6	1	9	2	0	6	0
2013	6	5	2	0	3	0	0	2	1
2017	4	2	0	0	0	0	0	2	2
2018	4	4	0	0	1	0	0	3	0
2019	22	20	5	1	1	0	1	17	2
2020	10	10	4	1	6	0	0	9	0
2021	17	16	1	1	1	0	5	13	1
2022	24	24	10	2	6	0	1	16	0
2023	61	61	47	5	36	0	0	47	0
2024	93	90	27	11	46	0	0	71	3
2025	85	82	25	14	45	0	0	72	3
2026	59	51	16	2	23	1	0	47	8

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Ganciclovir sodium, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Ganciclovir sodium, by the year in which FDA received them
Year	Reports
2004	10
2005	6
2006	9
2007	24
2008	9
2009	25
2010	47
2011	32
2012	23
2013	4
2016	1
2017	5
2018	7
2019	29
2020	15
2021	18
2022	24
2023	73
2024	86
2025	69
2026	52

Reports that name Ganciclovir sodium, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Ganciclovir sodium
Age	Reports	Share
Under 2	26	4.6%
2 to 11	30	5.3%
12 to 17	15	2.6%
18 to 44	125	22%
45 to 64	170	29.9%
65 to 74	65	11.4%
75 and over	20	3.5%
Age not given	117	20.6%

Sex of the patient in the reports that name Ganciclovir sodium
Sex	Reports	Share
Female	185	32.6%
Male	307	54%
Unknown or not given	76	13.4%

Type of reporter in the reports that name Ganciclovir sodium
Reporter	Reports	Share
Physician	154	27.1%
Pharmacist	34	6%
Other health professional	352	62%
Lawyer	0	0%
Consumer or non-health professional	21	3.7%
Not given	7	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ganciclovir sodium record
Indication as recorded (MedDRA)	Reports	Share
Cytomegalovirus infection	115	20.2%
Antiviral prophylaxis	34	6%
Cytomegalovirus viraemia	22	3.9%
Cytomegalovirus chorioretinitis	21	3.7%
Cytomegalovirus colitis	19	3.3%
Cytomegalovirus infection reactivation	12	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 568 reports.

Pages near this one

Ganciclovir same ingredient
Valcyte same class
Valganciclovir same class
Valganciclovir hydrochloride same class
Ganfort next in the A to Z list
Gamunex-C next in the A to Z list
Ganirelix next in the A to Z list
Gamunex C next in the A to Z list
Ganirelix acetate next in the A to Z list
Gamunex next in the A to Z list
Gardenal next in the A to Z list
Gammaplex next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Ganciclovir sodiumThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Ganciclovir sodium: adverse event reports that FDA received. https://reportedreactions.com/drug/ganciclovir-sodium/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Ganciclovir sodium as a suspect or interacting product. The 139 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Ganciclovir sodium was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Ganciclovir sodium?

No. It is a count of what people reported to FDA: 568 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (62%), physician (27.1%) and pharmacist (6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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